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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K220340
Device Name Amplatzer Steerable Delivery Sheath
Applicant
Abbott Medical
5050 Nathan Lane N
Plymouth,  MN  55442
Applicant Contact Emily Jallen
Correspondent
Abbott Medical
5050 Nathan Lane N
Plymouth,  MN  55442
Correspondent Contact Emily Jallen
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/07/2022
Decision Date 03/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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